NCT00308009

Comparison of the Result of TVT Performed at the Time of Prolapse Surgery or 3 Months After

Multicenter Prospective Randomized Trial Comparing to Strategies When Incontinence Surgery is Needed in Addition to Prolapse Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 194 (actual)
• Sponsor: Ullevaal University Hospital · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

It is unknown whether it is best to do the TVT( procedure for urinary stress incontinence in women) at the time of prolapse surgery or at a later date. Women with both conditions were randomized to both procedures together or the TVT 3 months after the prolapse surgery. Any or no leakage when couching was the main end-point, evaluated 1 year after the last surgery

Detailed description

All women were evaluated by the POP-Q (pelvic Organ Prolapse Quantification) prior to surgery and 1 year after. Examination for urinary leakage was done prior to surgery and 1 year after. Group 2 was also examined after prolapse surgery to see if TVT was still needed.

Conditions

• Pelvic Organ Prolapse
• Urinary Stress Incontinence

Interventions

Type	Name	Description
PROCEDURE	Vaginal Repair for prolapse, TVT procedure	1. TVT at the time of Vaginal Repair 2. TVT 3 months after Vaginal Repair
PROCEDURE	TVT and Prolapse surgery	1. TVT at the time of Prolapse surgery 2. TVT 3 months after Prolapse Surgery

Timeline

• Start date: 2002-02-01
• Primary completion: 2007-09-01
• Completion: 2007-09-01
• First posted: 2006-03-28
• Last updated: 2015-04-28